FDA Registration
Active
🇩🇪 Germany
HA2 MEDIZINTECHNIK GMBH
Reg #: 3009039068
·
FEI: 3009039068
·
Expires 2026
Products
53
Proprietary Names
186
Establishment Types
1
Classifications
53
Registration Details
- Registration Name
- HA2 MEDIZINTECHNIK GMBH
- Registration Number
- 3009039068
- FEI Number
- 3009039068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Am Bahndamm 11
- City
- Halberstadt Saxony-Anhalt
- Country
- DE
Owner / Operator
- Firm Name
- HA2 Medizintechnik GmbH
- Operator Number
- 10042677
- Address
- Am Bahndamm 11
- City
- Halberstadt
- State
- Saxony-Anhalt
- Postal Code
- 38820
- Country
- DE
- Correspondent
- Regina Koelzsch
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2023-12-22 |
| Hood, Oxygen, Infant | FOG | Class 1 | Anesthesiology | No | 2022-09-15 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2014-02-21 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2023-12-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-05-20 |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | Class 2 | General, Plastic Surgery | No | 2024-12-10 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2022-09-15 |
| System, Therapeutic, X-Ray | JAD | Class 2 | Radiology | No | 2026-01-15 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2022-07-01 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-05-08 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2023-03-28 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2023-12-22 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2023-12-22 |
| Femtosecond Laser System For Refractive Correction | OTL | Class 3 | Unknown | No | 2021-09-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-12-22 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2020-07-22 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2024-12-10 |
| Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | ODE | Class 2 | Gastroenterology, Urology | No | 2024-11-07 |
| Stent Graft, Infrapopliteal, Venous Arterialization | QWN | Class 3 | Unknown | No | 2023-12-11 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2025-01-03 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2015-06-24 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2015-06-24 |
| Valvulotome | MGZ | Class 2 | Cardiovascular | No | 2023-03-28 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-02-06 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2024-08-19 |
| Stylet, Ureteral | EYA | Class 1 | Gastroenterology, Urology | No | 2015-12-07 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2022-09-15 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-03-28 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2019-12-11 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2024-12-10 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2015-06-15 |
| Needle, Emergency Airway | BWC | Class 2 | Anesthesiology | No | 2022-06-17 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2022-06-17 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2023-12-22 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2023-05-08 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-02-06 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2015-06-24 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-12-10 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2015-06-24 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-02-20 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2025-03-25 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2018-02-16 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2022-07-01 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2021-08-24 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-05-03 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2023-03-28 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2015-06-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2023-06-07 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2015-06-24 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2023-12-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-12-10 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2022-01-20 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-12-22 |
Proprietary Names
NEEDLE, CONDUCTION, ANESTHETIC (W/WOINTRODUCER)
Flex-Catch NT
ACCESSORIES, CATHETER
MultiCut Solo
Eclipse
Halo
Venus
Dormia front
SonoPlex II
INTRABEAM SMART Spherical Applicator 50 mm (diam.)
INTRABEAM SMART Spherical Applicator 20 mm (diam.)
INTRABEAM SMART Spherical Applicator 35 mm (diam.)
INTRABEAM SMART Spherical Applicator 40 mm (diam.)
INTRABEAM SMART Spherical Applicator 45 mm (diam.)
INTRABEAM SMART Spherical Applicator 30 mm (diam.)
INTRABEAM SMART Spherical Applicator 15 mm (diam.)
INTRABEAM SMART Spherical Applicator 25 mm (diam.)
Lyoplant Onlay
SonoTAP NRFit
Dermatome - Blades For Dermatome And Mucotome; Dermatome; Mucotome
ELECTRODE, NEEDLE
Anesthesia conduction kit
Visumax Femtosecond Laser
SPROTTE® STANDARD
Syringe, piston
Confida Brecker Guidewire GWBC30
Stimuplex® Onvision® Needle
GERDX®-System
LimFlow System
MultiPulse HoPLUS
SchurSign Tissue Marker
MCL 31 Dermablate, Juliet
LimFlow Vector
Tubing Set
Lyoplant
Creos xenoprotect, Kontour Matrix, Zmatrix
UltraTrack guidewire
Apollo
Meridian
Slip
LimFlow ARC
Neuro Shield
Fiber Optic for PLA Short blue
Laser Surgery Fiber - Dental Bare Fiber 320?m
Fiber Optic for PLA Short yellow
Laser Surgery Fiber - Radial Emission 600?m Stopper
Laser Surgery Fiber Dental Bare Fiber 200?m
Fiber Optic for PLA Long yellow
Fiber Optic for MRI blue
Laser Surgery Fiber Chirurgie Bare Fiber 320?m
Laser Surgery Fiber - Radial Emission 600?m Vein
Laser Surgery Fiber - DiLAS® Laser Radial Venous Probe
Laser Surgery Fiber - Radial Emission 400?m Stopper
Fiber Optic for PLA Short green
Laser Surgery Fiber - DiLAS® Laser Hemorrhoid Probe
Laser Surgery Fiber - DiLAS® Laser Thyroid Probe
Fiber Optic for PLA Long blue
Laser Surgery Fiber - Radial Emission 400?m
Fiber Optic for PLA Short red
Corona 360 Fiber 600?m
Fiber Optic for MRI yellow
Laser Surgery Fiber Radial Emission 400?m Vein
Fiber Optic for PLA Long green
Laser Surgery Fiber - DiLAS® Laser PLDD Probe
Laser Surgery Fiber 600?m 2.6m
General Surgery Fiber 400um
Corona 360 Radial Fiber 600?m
Laser Surgery Fiber 600?m
Fiber Optic for PLA Long red
Fiber Optic for MRI red
Fiber Optic for MRI green
Dental Surgery Fiber 320?m
Radial Emission Fiber 400?m
Laser Surgery Fiber - DiLAS® Laser Slenderflex Venous Probe
Laser Surgery Fiber - DiLAS® Laser Fistula Probe
WAL Irrigation and Aspiration cannula (Model #: 502001)
WAL Irrigation and Aspiration cannula (Model #: 500088)
WAL Irrigation and Aspiration cannula (Model #: 500091)
Biofill applicator, for Biofill cannulas (for body-jet evo and body-jet eco only) (Model #: 580001)
WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, RAPID, single-use (Model #: 1501125)
WAL Irrigation and Aspiration cannula (Model #: 503002)
Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, single-use (Model #: 1580125)
body-jet eco, 230V / 120 V/ 100 V (Model #: 500000-8)
STS Irrigation/Aspiration cannula, 4.8mm D, 30cm L, 4 suction holes (Model #: 503136)
WAL Irrigation and aspiration cannula, 3.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503004)
WAL Irrigation/aspiration cannula, stainless steel, D 4.8mm, L 30cm, multi-hole, RAPID (Model # 503005)
harvest Aspiration cannula (Model #: 602012)
WAL Infiltration cannula (Model #: 500042)
harvest-jet Applicator (for harvest-jet and harvest cannulas only) (Model #: 601001)
WAL Irrigation and Aspiration cannula (Model #: 502002)
WAL Irrigation and aspiration cannula, 3 long suction holes, 3.8mm D, 30cm L, subcutaneous, single-use (Model #: 1502004
WAL Irrigation and Aspiration cannula (Model #: 500093)
WAL Irrigation and Aspiration cannula (Model #: 502003)
harvest Infiltration cannula (Model #: 602011)
WAL Infiltration cannula, 4.8mm D, 30cm L, single use (Model # 1500121)
WAL Irrigation and Aspiration cannula (Model #: 500136)
body-jet with weighing system, 120 V (Model #: 500000-1)
WAL Infiltration cannula (Model #: 500070)
WAL Infiltration cannula (Model #: 500121)
Biofill cannula (Model #: 580086)
body-jet evo, 120 V (Model #: 500000-17)
WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, single-use (Model #: 1500125)
harvest-jet without weighing system, 120 V (Model #: 500000-5)
Biofill cannula, 3.8mm D, 15cm L, 4 suction holes, RAPID (Model #: 581125)
WAL Irrigation and Aspiration cannula (Model #: 500119)
WAL Irrigation and Aspiration cannula, stainless steel, 3.8mm D, 15cm L, 2x2 long suction holes, RAPID (Model #: 501151)
WAL applicator, short (Model #: 500001K)
WAL Irrigation and Aspiration cannula, spoon-shaped tip (Model #: 500063)
WAL Irrigation and aspiration cannula, 4.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503005)
WAL Irrigation and Aspiration cannula (Model #: 500092)
STS Irrigation/Aspiration cannula, 4.2mm D, 30cm L, 4 suction holes (Model #: 503148)
WAL applicator (Model #: 500001)
STS Infiltration cannula, 2.5mm D, 25cm L (Model #: 503070)
WAL Irrigation and Aspiration cannula (Model #: 501092)
WAL Irrigation and Aspiration cannula (Model #: 500089)
WAL Irrigation and Aspiration cannula (Model #: 500148)
Biofill cannula, 3.8mm D, 15cm L, 4 suction holes (Model #: 580125)
WAL Infiltration cannula (Model #: 500028)
Spacer for 15 cm cannulas, non sterile, reusable (Model #: 500054)
WAL Irrigation and aspiration cannula, sterile, single use, 2.5 mm D, 15cm L, 180 spray jet straight (Model #: 500114S)
WAL Irrigation and Aspiration cannula (Model #: 500125)
WAL Irrigation and Aspiration cannula (Model #: 501089)
WAL Irrigation/aspiration cannula, stainless steel, D 3.8mm, L 30cm, multi-hole, RAPID (Model # 503004)
Biofill cannula, 2 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580086)
WAL Irrigation and Aspiration cannula (Model #: 502004)
WAL Infiltration cannula, 2.5mm D, 30cm L, single-use (Model #: 1500127)
STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes, RAPID (Model #: 503002)
WAL Irrigation and Aspiration cannula (Model #: 503001)
Biofill Infiltration cannula (Model #: 580107)
Hydrophobic filter set (Model #: 101947)
WAL Irrigation and Aspiration cannula (Model #: 501125)
WAL Applicator, 370 cm (for body-jet evo only) (Model #: 570001)
STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 3 suction holes, SUBCUTANEOUS (Model #: 503204)
WAL Irrigation and aspiration cannula, 4 long suction holes, 4.2mm D, 30cm L, single-use (Model #: 1500148)
WAL Irrigation and Aspiration cannula (Model #: 500149)
WAL Irrigation and Aspiration cannula (Model #: 501119)
Biofill cannula, 4 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580089)
WAL Infiltration cannula (Model #: 500107)
Biofill Infiltration cannula, 2.5mm D, 15cm L, single-use (Model #: 1580107)
Hydrophobic filter set (for body-jet evo) (Model #: 103532)
WAL Irrigation and Aspiration cannula (Model #: 500086)
Biofill cannula (Model #: 580089)
WAL Infiltration cannula (Model #: 503003)
Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, RAPID, single-use (Model #: 1581125)
WAL Irrigation and Aspiration cannula (Model #: 500117)
STS Infiltration cannula, 3.5mm D, 30cm L (Model #: 503003)
WAL Irrigation and aspiration cannula, 4 long suction holes, 4.8mm D, 30cm L, single-use (Model #: 1500136)
STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes (Model #: 503001)
STS Irrigation/Aspiration cannula, 3.5mm D, 30cm L, 4 suction holes (Model #: 503089)
SPROTTE® STANDARD 2.G
CATHETER, CONDUCTION, ANESTHETIC
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Sterile Cover Kit
NEURO-PATCH
RayPilot Power box
RayPilot Transmitter Cable
RayPilot Quality Control kit
RayPilot ViewCath
RayPilot Matching Network
RayPilot Table displacement meter
RayPilot System Cable
RayPilot Software
RayPilot HypoCath
RayPilot Extension plate
RayPilot Transmitter tester
RayPilot Receiver
Hydrofilm
Atrauman Silicone 20x30 P5
Atrauman Silicone 5x7 P5
Atrauman Silicone 5x7 P10
Atrauman Silicone 7,5x10 P5
Atrauman Silicone 10x20 P10
Atrauman Silicone 7,5x10 P10
Atrauman Silicone 10x20 P5
Lyograft
ATMOS S 201 Thorax
Sono MSK
PENTAX Medical Single Use Video Bronchoscope EB15-S01
PENTAX Medical Single Use Video Bronchoscope EB11-S01
LimFlow V-Ceiver
Spinal Burr
Support Tube
STIMULATOR, NERVE, BATTERY-POWERED
SonoBlock II Facet S
Transcodent Dental Needle
HANDLE,
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)